Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2022-002007-38
    Sponsor's Protocol Code Number:CLTP001A12201E1
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-12-22
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2022-002007-38
    A.3Full title of the trial
    An open-label extension study to investigate efficacy, safety and tolerability of LTP001 in participants with pulmonary arterial hypertension
    Estudio de extensión abierto en el que se investigan la eficacia, la seguridad y la tolerabilidad de LTP001 en participantes con hipertensión arterial pulmonar
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Extension study of efficacy and safety of LTP001 in pulmonary arterial hypertension participants
    Estudio de extensión de la eficacia y la seguridad de LTP001 en participantes con hipertensión arterial pulmonar
    A.4.1Sponsor's protocol code numberCLTP001A12201E1
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNovartis Farmacéutica, S.A.
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNovartis Pharma AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Farmacéutica, S.A.
    B.5.2Functional name of contact pointTrial Monitoring Organization (TMO)
    B.5.3 Address:
    B.5.3.1Street AddressGran vía de les Corts Catalanes, 764
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08013
    B.5.3.4CountrySpain
    B.5.4Telephone number+34930353036
    B.5.5Fax number+34932479903
    B.5.6E-maileecc.novartis@novartis.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameLTP001
    D.3.2Product code LTP001
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNnot available
    D.3.9.2Current sponsor codeLTP001
    D.3.9.3Other descriptive nameLTP001
    D.3.9.4EV Substance CodeSUB221265
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameLTP001
    D.3.2Product code LTP001
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNnot available
    D.3.9.2Current sponsor codeLTP001
    D.3.9.3Other descriptive nameLTP001
    D.3.9.4EV Substance CodeSUB221265
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Pulmonary arterial hypertension
    Hipertensión arterial pulmonar.
    E.1.1.1Medical condition in easily understood language
    Disease in which blood vessels (arteries) in the lungs are damaged. This
    inhibits blood flow and pressure in the lung arteries rises and eventually
    heart failure develops
    Enf. en la que se dañan los vasos sanguíneos(arterias) de los pulmones.Esta inhibe el flujo sanguíneo y la presión en las arterias pulmonares se eleva y finalmente se desarrolla insuficiencia cardiaca
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10064911
    E.1.2Term Pulmonary arterial hypertension
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the long-term safety of LTP001 in participants with pulmonary arterial hypertension (PAH)
    Evaluar la seguridad a largo plazo de
    LTP001 en participantes con hipertensión arterial pulmonar (HAP)
    E.2.2Secondary objectives of the trial
    - To assess the effect of LTP001 on hemodynamic parameters derived from RHC
    - To assess the effect of LTP001 on the 6MWD
    - To assess the effect of LTP001 on measurements of right ventricular function
    - To assess the impact of LTP001 on Time to Clinical Worsening
    - To assess the impact of LTP001 on patient reported outcomes
    - To assess the impact of LTP001 on the N-terminal fragment of the prohormone B-type natriuretic peptide
    - Evaluar el efecto de LTP001 en los
    parámetros hemodinámicos derivados del cateterismo cardíaco derecho (CCD)
    - Evaluar el efecto de LTP001 en la 6MWD
    - Evaluar el efecto de LTP001 en las
    mediciones de la función del ventrículo derecho
    - Evaluar el impacto de LTP001 en el tiempo hasta el empeoramiento clínico
    - Evaluar el impacto de LTP001 según los cuestionarios resultados comunicados por los pacientes
    - Evaluar el impacto de LTP001 en el fragmento N-terminal de la prohormona del péptido natriurético de tipo B
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Written informed consent must be obtained before any assessment is performed.
    • Participant is currently completing the Novartis-sponsored study CLTP001A12201 in PAH and completed key efficacy and safety procedures up to the end of treatment of the parent study, without meeting discontinuation criteria in the parent study.
    • Willingness and ability to comply with scheduled visits, treatment plans and any other study procedures.
    • Participant currently has no evidence of treatment failure, as determined by the investigator, following previous treatment.
    • In the opinion of the Investigator the participant would benefit from LTP001 treatment.

    Additional protocol-defined criteria may apply.
    - El consentimiento informado por escrito se debe obtener antes de realizar cualquier evaluación.
    - Participantes que actualmente estén completando el estudio CLTP001A12201 de HAP promocionado por Novartis y que hayan completado los procedimientos de eficacia y seguridad principales hasta el final del tratamiento del estudio principal sin cumplir ninguno de los criterios de discontinuación del estudio principal.
    - Voluntad y capacidad para cumplir con las visitas programadas, los planes de tratamiento y cualquier otro procedimiento del estudio.
    - Participantes que actualmente no presenten signos de no haber respondido al tratamiento, según determine el investigador, después del tratamiento anterior.
    - Participantes que, en opinión del investigador, se beneficiarían del tratamiento con LTP001.

    Pueden aplicarse otros criterios de inclusión definidos por el protocolo
    E.4Principal exclusion criteria
    • History of hypersensitivity to the study treatment.
    • Required or planned transplant or heart/lung surgery.
    • Acute or chronic impairment (other than dyspnea), which would limit the ability to comply with study requirements, including interference with physical activity or execution of study procedures such as 6MWT (e.g., angina pectoris, claudication, musculoskeletal disorder, need for walking aids).
    • Permanent discontinuation of Novartis drug in the parent study due to toxicity or disease progression, non-compliance to study procedures, withdrawal of consent or any other reason.

    Additional protocol-defined criteria may apply.
    - Antecedentes de hipersensibilidad al tratamiento del estudio.
    - Trasplante o cirugía de corazón/pulmón requeridos o previstos.
    - Deterioro agudo o crónico (salvo la disnea) que limite la capacidad de cumplir los requisitos del estudio, incluyendo la interferencia en la actividad física y la ejecución de los procedimientos del estudio como la 6MWT (p. ej., angina de pecho, claudicación, trastorno musculoesquelético o necesidad de dispositivos de ayuda para caminar).
    - Discontinuación permanente del fármaco de Novartis en el estudio principal debido a toxicidad o progresión de la enfermedad, incumplimiento de los procedimientos del estudio, retirada del consentimiento o cualquier otro motivo.

    Pueden aplicarse otros criterios de exclusión definidos por el protocolo.
    E.5 End points
    E.5.1Primary end point(s)
    AEs, SAEs, vital signs, ECGs, safety laboratory measurements
    AA, AAG, constantes vitales, ECG y
    mediciones de laboratorio de seguridad
    E.5.1.1Timepoint(s) of evaluation of this end point
    From Baseline to End-Of-Study
    Desde la basal hasta el final del estudio
    E.5.2Secondary end point(s)
    • Change from baseline for each hemodynamic parameters derived from RHC
    • Change in 6MWD from baseline
    • Change from baseline in tricuspid annular plane systolic excursion (TAPSE) by echocardiography
    • Change from baseline in tricuspid annular systolic velocity (TASV) by echocardiography
    • Change from baseline of peak velocity of excursion (RV S') by echocardiography
    • Change from baseline in fractional area change (FAC) by echocardiography
    • Change from baseline in EmPHasis-10 and PAH-SYMPACT
    • Time to clinical worsening including time to death, hospital stay due to worsening of PAH, worsening of PAH resulting in need for lung transplantation
    • N-terminal fragment of the prohormone B-type natriuretic peptide
    - Cambio en cada parámetro hemodinámico respecto a la basal derivado de CCD
    - Cambio en la 6MWD respecto a la basal
    - Cambio en el desplazamiento sistólico del plano del anillo tricuspídeo (DSPAT) respecto a la basal, mediante ecocardiografía
    - Cambio en la velocidad sistólica del anillo tricuspídeo (VSAT) respecto a la basal, mediante ecocardiografía.
    - Cambio en la velocidad máxima de desplazamiento (RV S') respecto a la basal, mediante ecocardiografía.
    - Cambio de área fraccional (CAF) respecto a la basal, mediante ecocardiografía.
    - Cambio en EmPHasis-10 y PAH-SYMPACT respecto a la basal
    - Tiempo hasta el empeoramiento clínico incluyendo muerte, ingreso hospitalario debido al empeoramiento de la HAP, empeoramiento de la HAP que conlleva la necesidad de trasplante de pulmón
    - Fragmento N-terminal de la prohormona del péptido natriurético de tipo B.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At week 26
    At week 26 and 52
    At week 26 and 52
    At week 26 and 52
    At week 26 and 52
    At week 26 and 52
    At week 5, 13, 26, 39 and 52.
    From baseline to End-of-Study
    At weeks 5, 12, 26, 39 and 52.
    En la semana 26
    En la semana 26 y 52
    En la semana 26 y 52
    En la semana 26 y 52
    En la semana 26 y 52
    En la semana 26 y 52
    En la semana 5, 13,26, 39 y 52.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    United States
    Poland
    Netherlands
    Spain
    Germany
    United Kingdom
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LSLV
    Última visita del último paciente (LPLV)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days13
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 28
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 12
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 16
    F.4.2.2In the whole clinical trial 40
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    Ninguno
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2023-03-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-02-28
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Thu May 02 21:35:50 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA